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Authors
Spain, Thomas J.
Hunt, Alexandra
Sudell, Maria
Hutton, Jane L.
Putter, Hein
Watson, Victoria
Blakey, John
Marson, Anthony
Bonnett, Laura Jayne https://orcid.org/0000-0002-6981-9212
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Funding
Funding for this research was provided by:
Academy of Medical Sciences (SBF008\1060)
National Institute for Health and Care Research (PDF-2015-08-044)
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Article History
Received: 10 March 2026
Accepted: 26 August 2026
First Online: 7 September 2026
Declarations
Ethics approval and consent to participate: The OPCRD was approved by the Trent Multi-Centre Research Ethics Committee for clinical research use. This study protocol was approved by the OPCRD’s Anonymised Data Ethics Protocols and Transparency Committee. There was no direct patient and public involvement (PPI) in this study, but the OPCRD was developed with PPI and is updated by a committee that includes patient representatives. SANAD received appropriate multicentre and local ethics and research committee approvals from the National Multi-Centre Research Ethics Committee North West (MREC 98/8/62), and was managed according to the Medical Research Council’s Good Clinical Practice Guidelines. Patients gave informed written consent to inclusion and to long-term follow-up. In the case of children (< 16 years), consent was obtained from the parent or guardian. SANAD is registered as an International Standard Randomised Controlled Trial, number ISRCTN38354748, registration date 25th April 2003.
Consent for publication: Not applicable.
Competing interests: The authors declare no competing interests.
